Closed system connector assembly

ABSTRACT

A male adaptor is provided with a nose for penetrating into a housing of the female connector. A septum is disposed over the nose of the male adaptor to maintain a seal with the female connector during coupling and uncoupling. Upon coupling, the septum dilates to allow the nose to pass through. The female connector may have a septum that also dilates to allow penetration of the nose of the male adaptor. Alternatively, the septum of the female connector may be retractable under the force of the nose of the male adaptor.

This application claims the priority benefit of Provisional PatentApplication 60/317,143 filed Sep. 6, 2001.

This invention relates to a closed system connector assembly. Moreparticularly, this invention relates to a closed system connectorassembly having a swabable male adaptor and a swabable female connectorfor use particularly in the health care industry.

As is known, the health care industry is concerned with microorganisms,such as bacteria and the like, which may cause health problems. In somecases, people become patients because these microorganisms becomeunmanageable and threaten or endanger the health of the patient.

Patients requiring therapy are often placed in a position where theirnormal defenses against microorganisms are compromised. As a result, thepatients may develop nosocomal infections while being treated foranother disease during therapy. As has been recognized, a major cause ofnosoicomal infections has been due to the connection/disconnection oftubing lines, especially in the area of IV therapy. This is one of thereasons why most IV Administration Sets (IV tubing with connectors) arediscarded every forty-eight to seventy two hours.

In the development of connectors for tubing lines, primary concern hasgenerally been with having a connector which can readily be closed andsealed and just as readily be opened with a minimum of force. Aso-called luer connection is the generally accepted standard for thehealth care industry. This connector is easy to open and close andrequires little force while at the same time providing a positive seal.However, one disadvantage of this connector is that after fluid flowsthrough a connection made by the connector, if the user wishes to openthe connection and then reconnect the connection, the chance ofmicroorganism contamination is sufficiently large that most hospitals donot allow this practice except under abnormal circumstances.

In order to provide a system, which can be connected, for the transferof medication, followed by a sterile disconnection, the use of a Y-siteconnector has been developed. In this case, the connection is in theform of a plastic fitting having one end covered with a rubber septum.In order to deliver fluid into the connector, a sterile needle piercesthrough the rubber septum in order to transfer fluid into the line towhich the connection is connected. After fluid transfer is completed,the needle is removed and the rubber septum self closes to maintain whatis commonly referred to as a closed system and sterility of the line ismaintained. Everything associated with the now removed needle isconsidered to be non-sterile since the exit port of the needle isexposed to the atmosphere and almost immediately becomes contaminated.

U.S. Pat. No. 5,122,123 describes a product, which has membranes on bothparts of the connection assembly. One part further contains a cannula,which has about it a membrane, which is collapsible. Upon joining thetwo portions of the connector together, the one membrane collapses asthe cannula enters the other portion of the connector thereby openingthe septum and providing for a continuous passage for fluid flow. Upondisconnect, the cannula is resheathed within the membrane prior toremoval thereby maintaining a sterile path within both portions of theconnector assembly. This assembly requires two connector halves, whichare uniquely designed to mate with each other. As a result, existingconnector products are generally not viable when a connector half doesnot contain a membrane or the membrane opens when the central portion ofthe connector is forced inward by the action of a male luer adaptor.

Accordingly, it is an object of this invention to provide a connectorassembly, which can be readily made sterile on site immediately prior toforming a connection.

It is another object of this invention to provide a connector, which canbe used with existing available connectors to achieve a sterileconnection/disconnection.

Briefly, the invention provides a closed system connector assemblycomprising a male adaptor attached to a female connector. The femaleconnector may be a needleless type generically described as a pressureopening swabable valve that opens upon the attachment of a male luerconnector portion. Swabable valves of the needleless type include theCLC 2000 made by ICU Medical, POSIFLOW, made by Becton Dickinson. Othervalves of this type are made by B. Braun and Kippmed to name a few.

The male adaptor of this invention is constructed with a tubular portionto define a lumen and a membrane or septum at one end of the tubularportion for sealing the lumen.

The female connector to which the male adaptor connects has a housingdefining a lumen and a membrane or equivalent surface that may beswabbed to achieve a sterile interface for sealing the lumen and forabutting the membrane of the male connector.

Upon movement of the male adaptor against the female connector swabableface (membrane), the membrane covering the nose of the male adaptor isopened exposing the tubular lumen which enters the female connectorhousing. As the nose portion moves into a housing of the femaleconnector, the female connector housing lumen is opened to provide fluidcommunication between the connectors. The face portion of the maleadaptor membrane engages the flange or face of the female connectorhousing forming a seal between the two connectors with the outsideenvironment. Upon uncoupling, the female connector closes prior toremoval of the nose portion of the male adaptor. As the male adaptordisengages from the female connector, the septum closes prior to theexposure of the male lumen to the environment thereby maintaining asterile fluid path in both the male adaptor and the female connector.

In this manner, a sterile connection is achieved with an existingneedleless pressure opening connector which is swabable to achievesterility at the face prior to use. The closed system connector allows asterile connection to be achieved many times by simply swabbing bothsystem connector halves prior to connection.

In another embodiment, the female connector may include a hollow needledisposed within the lumen that is positioned for entry into the lumen ofthe male adaptor.

These and other objects and advantages of the invention will become moreapparent from the following detailed description taken in conjunctionwith the accompanying drawings wherein:

FIG. 1 illustrates a cross-sectional view of the male adaptor portion ofa closed system connector constructed in accordance with the inventionwith a reseal member thereof in a first, closed position;

FIG. 2 illustrates a cross sectional partial view of a commercialneedleless connector;

FIG. 3 illustrates a cross sectional view of the male adaptor of FIG. 1in abutment with the female connector of FIG. 2;

FIG. 4 illustrates a cross sectional view of the male adaptor of FIG. 1penetrating the female connector of FIG. 2;

FIG. 5 illustrates a cross sectional view similar to FIG. 4 with of aportion of the swabable membrane of the male adaptor opened and pushedup the housing of the male adaptor.

FIG. 6 illustrates a cross sectional view of a portion of a swabablevalve which has a central mandrel;

FIG. 7 is a cross sectional view of the swabable valve of FIG. 6connected to the tubular portion of the male adaptor of FIG. 1;

FIG. 8 illustrates a cross-sectional view of needle containing femaleconnector; and

FIG. 9 illustrates a cross-sectional view of the female connector ofFIG. 8 connected to a male adaptor of FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIG. 1, the male adaptor 10 includes a housing 18 having aprojecting nose or tubular portion 14 and a passage or lumen 15 thatextends centrally therethrough. As illustrated the outer surface of thenose 14 is tapered downwardly towards the forward end.

In addition, the adaptor 10 has a locking ring 11 mounted concentricallyof the nose 14 that is provided with an internal thread 20. The lockingring 11 is locked in place on the nose 14 by the relative dimensions ofan integral ring 16 on the nose 14 and an internal ring or collar 17 onthe end of the locking ring 11. The ring 16 has a greater outsidediameter than the inside diameter of the ring 17 to create aninterference fit preventing the locking ring 11 from moving along thenose 14. The locking ring 11 in this embodiment is free to rotate aboutthe axis of the nose 14.

A septum or membrane 12 is mounted on the nose 14 to close over thepassage 15. This septum 12 includes a disk-shaped body 12′ sealing overthe passage 15 and a tubular sleeve 12″ that extends over the nose 14.The disk-shaped body 12′ has a flat swabable surface coincident with theend of the locking ring 11. As such, the face of the septum 12 can beeasily swabbed prior to use.

As illustrated, the septum 12 has an internal flange at one end thatfits into an annular groove 41 in the nose 14 to secure the septum 12 inplace. In addition, the septum 12 has a weakened section 13, such as aslit or pierced point, centrally of the disk-shaped body 12′ that is inline with the passage or lumen 15.

The housing 18 is typically sterilized and may be connected to a tubingor have an end connector (not shown) for attachment to a fluid sourcefor administration.

Referring to FIG. 2, the female connector 19 is in the form of aneedleless injection site. As indicated, the female connector 19includes a hollow housing 24 with an external thread 21 for threading ofthe locking ring 11 thereon (see FIG. 5). As indicated in FIG. 5, theforward end of the housing 24 has an internal wall that is tapered toreceive the tapered nose 14 of the male adaptor 10.

In addition, the female connector 19 has a centrally disposed tubularmember 28 disposed concentrically within the housing 24 to define apassage or lumen therethrough. The tubular member 28 carries a segmentedsleeve 23 that is slidably mounted thereon under the bias of a spring(not shown) to move from a retracted position, as shown in FIG. 5, to anextended position, as shown in FIG. 2. The sleeve 23 is formed with aplurality of leaf spring-like elements that project beyond the tubularmember 28 and that are bent or angled radially inwardly for purposes asdescribed below.

A septum or membrane 22 is mounted on the segmented sleeve 23 to sealoff the lumen of the tubular member 28. As shown, the septum 22 has aflat disk-like body 22′ with a flat face at the entry to the housing 24,a bulbous portion 22″ extending into the segmented sleeve 23 and atubular sleeve 30 fitted over the segmented sleeve 23 and securedthereto in a suitable manner. The flat face of the body 22′ of theseptum 22 is coincident with a face 51 of the housing 24 so as to beswabable prior to use. In addition, the flat body 22′ of the septum 22has slit 29 aligned with the passage in the tubular member 28.

As illustrated, the body 22′ of the septum 22 is slidably received inthe tapered forward end of the housing 24 and forms a seal thereat. Inaddition, the housing 24 has a recessed portion 35 of greater insidediameter than the forward portion to accommodate expansion of thesegmented sleeve 23 as explained below.

Referring to FIG. 3, wherein like reference characters indicate likeparts as above, prior to connecting the male adaptor 10 and the femaleconnector 19, the respective septums 12, 22 of each component is swabbedfor sterilization purposes. Next, the male adaptor 10 is brought upagainst the female connector 19. At this time, the septum 12 of the maleadaptor 10 abuts against the septum 22 of the female connector 19 tomaintain a sterile contact. At the same time, the outer periphery of theflat body 12′ of the septum 12 abuts against the face 51 of the housing24.

Next, the male adaptor 10 is pushed towards the female connector 19. Atthis time, the nose 14 of the male adaptor 10 being of less outsidediameter than the inside diameter of the connector housing 24 causes theflat body 12′ of the septum 12 to distort so that the slit 13 dilates tothereby open to allow penetration of the nose 14 into the housing 24 thefemale connector 19. At this time, the housing 24 of the femaleconnector 19 pushes the dilated body 12′ of the septum 12 along the nose14 as indicated in FIG. 5 to a retracted position. In this position, thesleeve 12″ of the septum 12 resiliently collapses into a bellows shape.

Further, as the nose 14 penetrates the housing 24 of the femaleconnector 19, the septum 22 therein is pushed rearwardly into therecessed portion 35. At this time, the sleeve 23 is also pushedrearwardly so that the inwardly bent leaf spring elements of thesegmented sleeve 23 expand radially outwardly as they pass over the endof the tubular member 28. This in turn, causes the slit 29 of the septum22 to dilate to form a passage 31. In this way, the passage 15 of themale adaptor 10 comes into communication with the lumen of the tubularmember 28 to allow fluid to pass therebetween.

Continued movement of the nose 14 into the connector 19 causes the leafspring elements to flex further outwardly to the condition shown in FIG.5 thereby further dilating the passage 31.

When the leaf spring elements of the segmented sleeve 23 are in theposition illustrated in FIG. 3, the forward end of the housing 24prevents outward flexing of the leaf spring elements.

As indicated in FIG. 5, the resiliently collapsed septum 12 maintains aseal tight fit against the face 51 of the housing 24 of the femaleconnector during the connection process of the male adaptor 10 to thefemale connector 19.

Upon disconnecting the male adaptor 10 from the female connector 19, thenose 14 retracts from the body 22′ of the septum 22. The leaf springelements then flex inwardly causing the body 22′ to circumferentiallycollapse to a diameter sufficient to allow passage of the body 22′ intothe forward end of the housing 24. Continued withdrawal of the nose 14from the housing 24 allows the segmented sleeve 23 to be spring biasedback to the extended position of FIG. 3. At this time, the leaf springelements of the segmented sleeve 23 also collapse back into the positionillustrated in FIG. 3 so that the septum body 22′ closes and again sealsagainst the inside wall of the housing 24 thereby maintaining the femaleconnector 19 in a sterile condition.

As the nose 14 is being withdrawn from the housing 24 the femaleconnector 19, the sleeve 12″ of the septum 12 expands from the positionof FIG. 5 towards the position indicated in FIG. 3 while remaining insealing contact with the housing 24. As the nose 14 achieves theposition shown in FIG. 3, the body 12′ of the septum 12 closes over thepassage 15 of the nose 14 while remaining in contact with the face 51 ofthe connector 24. This maintains the passage 15 of the male adaptor 10in a sterile condition.

Referring to FIG. 4, wherein like reference characters indicate likeparts as above, the locking ring 11 may be mounted over the nose 14 ofthe male adaptor without being locked thereon. In this embodiment, thelocking ring 11 is free to move axially relative to the nose of theadaptor. Thus, the locking ring 11 may be threaded onto the femaleconnector 24 before the nose 14 of the male adaptor is pushed into thehousing 24 of the female connector.

The locking ring 11 may be mounted on the male adaptor and held in placeby posts (not shown) on the housing 18 that align with key locks (notshown) on the internal flange of the locking ring 11. When the postsalign with the key lock, the locking ring 11 may be moved axiallyrelative to the housing 18.

Referring to FIG. 6, the female connector may be constructed with ahousing 51 having an external thread within which a mandrel 54 isslideably mounted. As indicated, the mandrel 54 has an inclined face 53and is sealed relative to the forward end of the housing 51 by a sealingring 52. In addition, the housing 51 is provided with a recess 57 inorder to form an annular space or gap between the housing 51 and themandrel 54 for the passage of fluid.

Referring to FIG. 7, wherein like reference characters indicate likeparts as above, as the tapered nose 14 of the male adaptor 10 is pushedinto the housing 51 of the connector, the mandrel 54 is pushedbackwardly in order to expose the annular gap between the housing 51 andthe mandrel 54 to the passage 15 in the male adaptor 10. As above, theseptum 12 on the male adaptor 10 moves up the tapered nose 14 therebyopening the septum 12 while maintaining a seal between the septum 12 andthe face of the housing 51.

Referring to FIG. 8, the female connector may be constructed with atubular housing 61 having an external thread and a hollow needle 62disposed concentrically within the housing 61. In addition, a tubularmember 63 is disposed concentrically between the housing 61 and theneedle 62 to define a passage 64 therethrough. In addition, a septum 65is formed integrally with the tubular member 63 to seal off the passage64. This septum 65 also has a centrally disposed slit 69 and a ring 66disposed circumferentially of the septum 65 to maintain a compressiveforce on the slit 69 to maintain the slit 69 closed.

Referring to FIG. 9, wherein like reference characters indicate likeparts as above, when the male adaptor is inserted into the connector ofFIG. 8, the septum 65 is pushed backwardly from the position shown inFIG. 8 to allow the needle 62 to pass through the slit 69 of the septum65. To this end, the needle has an opening 67 in a side wall and a bluntend 68 to avoid coring of the septum 69.

As shown in FIG. 9, the tubular member 63 collapses resiliently into abellows shape. Upon retraction of the male adaptor, the tubular portion63 springs back into the condition illustrated in FIG. 8 to allow theseptum 65 to again seal off the passage 64.

The invention thus provides a male adaptor which is able to maintain asealed passageway for fluids during coupling with and uncoupling from afemale connector.

Further, the invention provides a closed system connector assemblywherein a male adaptor and a female connector may be readily madesterile on site immediately prior to performing a connection andmaintained sterile after disconnection.

1-8. (canceled)
 9. A closed system connector assembly comprising a maleadaptor including a first housing having a projecting nose and a passageextending centrally therethrough, a locking ring mounted concentricallyabout said nose, and a first septum mounted on said nose and including adisk shaped body sealing over said passage and a tubular sleeveextending over said nose, said disk shaped body having a swabablesurface coincident with an end of said locking ring; and a femaleconnector including a second housing having an external thread forthreading into said locking ring of said male adaptor and being of aninternal diameter to receive said nose of said male adaptor therein, anda tubular mandrel slidably mounted within said second housing between afirst position in sealed relation to said housing and a retracted secondposition in spaced concentric relation to said housing to define anannular path therebetween, said mandrel having a swabable surfacecoincident with an end of said second housing and being of a diameter toabut said nose of said male adaptor.
 10. A closed system connector asset forth in claim 9 wherein said mandrel has an inclined face.
 11. Aclosed system connector assembly comprising a male adaptor including afirst housing having a projecting nose and a passage extending centrallytherethrough, a locking ring mounted concentrically about said nose, anda first septum mounted on said nose and including a disk shaped bodysealing over said passage and a tubular sleeve extending over said nose,said disk shaped body having a swabable surface coincident with an endof said locking ring; and a female connector including a second housinghaving an external thread for threading into said locking ring of saidmale adaptor and being of an internal diameter to receive said nose ofsaid male adaptor therein, a needle disposed concentrically within saidsecond housing, a resiliently collapsible tubular member disposedconcentrically within said second housing and a second septum mounted onsaid tubular member and having a swabable surface coincident with an endof said second housing, said second septum having a slit aligned withsaid needle for passage of said needle therethrough in response to saidnose pushing said second septum into said second housing.
 12. A closedsystem connector assembly comprising a male adaptor including a firsthousing having a projecting nose and a first passage extending centrallytherethrough, a locking ring mounted concentrically about said nose, anda first septum mounted on said nose and sealing over said first passage,said septum having an exposed swabable surface at an end of said lockingring; and a female connector including a hollow second housing having anexternal thread for threading into said locking ring of said maleadaptor and being of an internal diameter to receive said nose of saidmale adaptor therein, a tubular member disposed concentrically withinsaid second housing and defining a second passage therethrough, and asecond septum on said tubular member and sealing over said secondpassage and having an exposed swabable surface at an end of said secondhousing for abutting said swabable surface of said first septum.
 13. Aclosed system connector as set forth in claim 12 further comprising ahollow needle disposed concentrically in said tubular member of saidfemale connector.
 14. A closed system connector as set forth in claim 12wherein said second septum extends beyond said tubular member and has aslit disposed centrally thereof.
 15. A closed system connector assemblyas set forth in claim 12 wherein said first septum includes a diskshaped body sealing over said passage, a tubular sleeve extending oversaid nose and a centrally disposed slit in said body whereby uponpenetration of said nose of said male adaptor into said second housingof said female connector, said body of said first septum dilates aboutsaid nose and said housing of said female connector pushes said dilatedbody along said nose to a retracted position.
 16. A closed systemconnector assembly as set forth in claim 15 wherein said tubular sleeveof said first septum is resiliently collapsible during movement of saiddilated body along said nose to said retracted position whereby uponremoval of said nose from said female connector, said sleeve extends toreturn said dilated body over said passage in said tubular member.
 17. Aclosed system connector as set forth in claim 15 wherein said tubularmember is longitudinally collapsible.
 18. A closed system connectorassembly comprising a male adaptor including a first housing having aprojecting nose and a passage extending centrally therethrough, alocking ring mounted concentrically about said nose, and a first septummounted on said nose and including a disk shaped body sealing over saidpassage and a tubular sleeve extending over said nose, said disk shapedbody having an exposed swabable surface at an end of said locking ring;and a female connector including a hollow second housing having anexternal thread for threading into said locking ring of said maleadaptor and being of an internal diameter to receive said nose of saidmale adaptor therein, a tubular member disposed concentrically withinsaid second housing and defining a passage therethrough, and a secondseptum mounted on said tubular member and having an exposed swabablesurface at an end of said second housing for abutting said swabablesurface of said disk shaped body
 19. A closed system connector assemblyas set forth in claim 18 wherein said first septum includes a centrallydisposed slit whereby upon penetration of said nose of said male adaptorinto said second housing of said female connector, said body of saidfirst septum dilates about said nose and said housing of said femaleconnector pushes said dilated body along said nose to a retractedposition.
 20. A closed system connector assembly as set forth in claim19 wherein said tubular sleeve of said first septum is resilientlycollapsible during movement of said dilated body along said nose to saidretracted position whereby upon removal of said nose from said femaleconnector said sleeve extends to return said dilated body over saidpassage in said tubular member.
 21. A closed system connector assemblyas set forth in claim 20 wherein said tubular sleeve of said firstseptum includes an internal flange at one end and said nose has anannular groove receiving said flange therein.
 22. A closed systemconnector as set forth in claim 18 further comprising a hollow needledisposed concentrically in said tubular member of said female connector.23. A closed system connector assembly comprising a male adaptorincluding a first housing having a projecting nose and a passageextending centrally therethrough, a locking ring mounted concentricallyabout said nose, and a first septum mounted on said nose and including adisk shaped body sealing over said passage and a tubular sleeveextending over said nose, said disk shaped body having an exposedswabable surface at an end of said locking ring; and a female connectorincluding a second housing having an external thread for threading intosaid locking ring of said male adaptor and being of an internal diameterto receive said nose of said male adaptor therein, and a tubular mandrelslidably mounted within said second housing between a first position insealed relation to said housing and a retracted second position inspaced concentric relation to said housing to define an annular paththerebetween, said mandrel having an exposed swabable surface at an endof said second housing and being of a diameter to abut said nose of saidmale adaptor.
 24. A closed system connector as set forth in claim 23wherein said mandrel has an inclined face.
 25. A closed system connectorassembly comprising a male adaptor including a first housing having aprojecting nose and a passage extending centrally therethrough, alocking ring mounted concentrically about said nose, and a first septummounted on said nose and including a disk shaped body sealing over saidpassage and a tubular sleeve extending over said nose, said disk shapedbody having an exposed swabable surface at an end of said locking ring;and a female connector including a hollow second housing having anexternal thread for threading into said locking ring of said maleadaptor and being of an internal diameter to receive said nose of saidmale adaptor therein, a needle disposed concentrically within saidsecond housing, a resiliently collapsible tubular member disposedconcentrically within said second housing and a second septum mounted onsaid tubular member and having an exposed swabable surface at an end ofsaid second housing, said second septum having a slit aligned with saidneedle for passage of said needle therethrough in response to said nosepushing said second septum into said second housing.